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| 中药配方颗粒变更上市备案现状及建议 |
| Present Situation and Suggestions on the Listing of Traditional Chinese Medicine Formula Granules |
| 投稿时间：2024-02-08 修订日期：2024-04-07 |
| DOI： |
| 中文关键词: 中药配方颗粒 高质量发展 变更上市备案 中药科学监管 |
| 英文关键词: traditional Chinese medicine formula granules high -quality development change after listing for record scientific regulation of traditional Chinese medicine |
| 基金项目: |
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| 摘要点击次数: 28 |
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| 中文摘要: |
| 目的:以山东省为例,对中药配方颗粒变更上市备案情况进行研究,为变更的规范开展和科学监管提供参考。方法:分析国家及山东省变更上市备案相关法规和实际情况,汇总变更存在问题,并对变更上市备案资料要求等提出合理化建议。结果:总结中药配方颗粒备案工作开展两年以来的变更实践经验,对变更备案的资料要求提出意见建议。结论:为确保中药配方颗粒的变更质量,建议监管方加强政策引领和技术指导,企业发挥主体责任、科学评估变更的必要性和合理性,多举措保障中药配方颗粒产业高质量发展,为中药科学监管提供参考。 |
| 英文摘要: |
| Objective: Taking Shandong province as an example, this paper studies the present situation of listed change of traditional Chinese medicine formula granules(TCMFGs), which provides reference for the standardization and scientific supervision of the change. Methods: This paper analyzes the relevant laws and regulations of the State and Shandong province, summarizes the problems existing in the changes, and puts forward some suggestions on the requirements of the changes.? Results: This paper summarizes the practical experience of the change of the record-keeping of TCMFGs in the past two years, and puts forward some suggestions on the information requirements of the change.? Conclusion: In order to ensure the quality of the change of TCMFGs, it is suggested that the supervisor should strengthen the policy guidance and technical guidance, and the enterprises should play the main responsibility and scientifically evaluate the necessity and rationality of the change, many measures should be taken to ensure the high-quality development of TCMFGs and provide reference for the scientific regulation of Chinese medicine. |
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